Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficiency of autologous adipocytes graft in endoscopic treatment in vesico-renal reflux in children

Conditions: Vesico-Ureteral Reflux

Summary: urinary tract infection (uti) is a common problem in childhood associated with vesico-renal reflux (vrr) in 25-40% of children. a persistent vrr and repeated pyelonephritis may predispose to renal scarring and chronic renal failure with an end-stage renal failure in up to 3% of children.defining a standard behaviour facing vrr in children is not easy because of the lack of reliable evidence. numbers of studies compare prospectively or retrospectively, medical, endoscopical and surgical treatment.surgical techniques are effective but invasive and not free of complication. medical treatment is submissive to a good observance. the introduction of endoscopic techniques permits to prevent uti and new renal failure by vrr elimination. since the beginning of the endoscopic treatment, several bulking agents have been proposed. the ideal agent should be easy to inject, stable in time and should be safe. of course it should be at least as efficient as actual bulking agent. the use of teflon was the first wave of success of endoscopic treatment. but sudden passion of teflon has been darkened by the notion of migration. since, others substances have been proposed, autologous or exogenous, resorbable or not. but none was ideal and no solutions were found facing problem of biocompatibility or long-term stability.using adipose tissue as a bulking agent is ancient in plastic surgery and indications had known a leap forward in the last century with coleman who introduced a new technique called "lipostructure". this technique has known a growing interest in the restoration of all volume defects in plastic surgery because of the stability of the graft. we propose to apply this technique to vrr management in children in order to combine innocuousness and efficiency.


Eligibility criteria:
inclusion criteria : * sexe : male and female * age : 3 to 15 years * written consent * vesico-renal reflux staged i to iii revealed by a pyelonephritis ; after failure of medical treatment or parent refusal of medical treatment or initial renal failure. exclusion criteria : * before 3 years or older than 15 years * insulino-dépendant diabet * neurologic bladder * abnormalities of the urinary tract * kidney transplantation * past history of bladder surgery * anorexia (bmi \<12) * vesico-renal reflux staged iv or v * active urinary tract infection

Keywords: vesico-ureteral reflux, autologous adipocytes, adipocytes graft
seizures post intracerebral hemorrhage

Conditions: Post Cerebral Hemorrhage

Summary: this study examines early antiepileptic treatment with valproic acid for acute cerebral hemorrhage against a placebo group immediately post event to evaluate the outcome of these patients regarding seizures and neurological outcome.


Eligibility criteria:
inclusion criteria: * cerebral hemorrhage spontaneous exclusion criteria: * early seizures
safety and efficacy of intravitreal fluocinolone acetonide implants in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this is a 3-year randomized, dose masked, three-arm controlled, pilot study to evaluate the safety and efficacy of the intravitreal fa implants (0.59mg and 2.1mg), when compared to laser photocoagulation in the treatment of patients with diabetic macular edema.


Eligibility criteria:
inclusion criteria: * subjects with type 1 or 2 diabetes. * subjects with clinically significant macular edema as defined by the etdrs. * a best corrected visual acuity between +0.30 and +1.00 logmar (70 and 35 letters or approximately 20/40 to 20/200) as measured on an etdrs chart. * subjects with laser treatment status/history as follows: \[1\] naïve to laser photocoagulation or focal laser photocoagulation more than 16 weeks prior to screening or prp more than 24 weeks prior to screening, \[2\] no laser scars within 500µm (4x the width of a retinal vein at the disc margin) of the central macula. * the subject's ocular media had to be sufficiently clear to allow for quality fundus photography. * if aphakic or pseudophakic, lens removal had to have occurred at least 40 weeks prior to screening. * subjects had to be males or non-pregnant females of at least 18 years. * subjects had to display the ability and willingness to comply with treatment, follow up process, and sign an informed consent form. exclusion criteria: * subjects who have had previous grid macular photocoagulation for diffuse macular edema. * presence of posterior hyaloid membrane, epiretinal membranes, fibrovascular proliferation, and vitreopapillary traction, which causes tractional distortion on the macula as demonstrated by oct or funduscopy. * history of or current retinal detachment requiring surgical treatment or a scleral buckle. * diabetic retinopathy that required immediate prp. * ocular disease other than diabetic retinopathy that could confound the outcome of the study (e.g., age-related macular degeneration, drug toxicity, uveitis, hypertensive retinopathy, ischemic maculopathy, etc.). * glaucoma, or history of glaucoma in either the study eye or the fellow eye. * ocular hypertension, or history of ocular hypertension requiring iop lowering treatment. * a media opacity that precludes visualization and/or diagnosis of the status of the eye. * concurrent coumadin therapy or known bleeding diathesis. * subjects requiring chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to manage non-ocular disease. * concurrent treatment with a new investigational drug. * subjects with a best-corrected visual acuity worse than +1.0 logmar (20/200 or 35 etdrs letters) in the fellow eye. * pregnant or lactating females. * females of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy. * history of hypersensitivity to fluorescein, known allergies to steroids or any component of the intraocular device. * subjects with photophobia that will preclude the ability to do fundus evaluations.
importance of patient´s satisfaction with telemedicine based on monitoring systems

Conditions: Arrythmia

Summary: valiosa is a national, multicenter and prospective post market study. the objectives of the study are to generate and validate an instrument to evaluate patient and clinician's satisfaction with remote monitoring and to create awareness of the importance of remote monitoring among patients, physicians and decision makers.


Eligibility criteria:
inclusion criteria: 1. patients- naïve in carelink®: * first implant patients, who initiate in carelink® * replacements patients who initiate in carelink. 2. long term users in carelink®: patients in carelink for more than a year. 3. both male and female 4. more than 18 years old. 5. be at the disposal of using carelink monitoring system. 6. complete informed consent and accept the conditions of carelink system. exclusion criteria: 1. less than 18 years old 2. suffer from any menthal pathology who prevents the patient to collaborate in the study. 3. be unable to understand or answer questionnaires in spanish. 4. deny to continue in the study.

Keywords: remote monitoring satisfaction telemonitoring quality of life
collateral damage from the covid-19 pandemic observed in patients treated with intravitreal injections (ivt) of anti-angiogenic agents

Conditions: Age Related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Summary: in patients treated for exudative age-related macular degeneration (amd), diabetes, retinal venous occlusion (ovr), or other conditions causing macular edema, treatments with anti-angiogenic intravitreal injections (ivt) are widely used both for their anti-angiogenic action. patients often have injections for many years, sometimes monthly or every 2 months. the discontinuation of treatment with repeated injections of anti-angiogenic agents, linked to the covid-19 coronavirus pandemic will potentially impact the visual acuity, the ophthalmological state and the quality of life of the patients concerned, therefore it is relevant to analyze the consequences the breakdown of usual care in this population.


Eligibility criteria:
inclusion criteria: * ocular pathology requiring repeated ivt treatment of anti-angiogenic drugs (exudative amd, diabetic macular edema or secondary to retinal venous occlusion ...) * beginning of ivt treatment repeated before 10/01/2019 (6 months before the start of french confinement) exclusion criteria: * refusal to participate

Keywords: intravitreal injections anti-angiogenics covid19
the use of amantadine in the prevention of progression and treatment of covid-19 symptoms

Conditions: COVID-19; SARS-CoV-2

Summary: the use of amantadine in the prevention of progression and treatment of covid-19 symptoms in patients infected with the sars-cov-2 virus. multicenter randomized, double-blind, placebo-controlled, non-commercial clinical trial


Eligibility criteria:
inclusion criteria: * men and women aged 18 and over * can give informed consent * confirmed positive result for sars-cov-2 within 72 hours from the date the result was issued (according to the laboratory report) * patient presently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnoea, chest pain, diarrhea, nausea, vomiting, anosmia, lack of taste, sore throat, nasal congestion * at initial screening, the subject will report at least one and no more than 3 of the following risk factors for clinical worsening: age ≥40, obesity, hypertension, diabetes, pulmonary disease (e.g., asthma, copd), and immune disorders (e.g. rheumatoid arthritis, lupus), neurological diseases: e.g. after a distant stroke or trauma to the brain, multiple sclerosis, dementia and other neurodegenerative diseases) * patients hospitalized due to meeting the above criteria and requiring observation in a hospital or outpatient setting. exclusion criteria: * disease severe enough to meet the study's primary endpoint of clinical worsening (eg, current o2 saturation \<92% with patient exposure to room air, current use of supplemental oxygen to maintain o2 saturation ≥ 92%). * who score ≥4 (requires oxygen therapy during hospitalization) * concomitant diseases which, in the opinion of the attending physician, prevent the patient from participating in the study, such as: decompensated cirrhosis, active ulcer disease, epilepsy and symptomatic convulsions, untreated angle-closure glaucoma determined on the basis of the patient's interview and / or medical documentation . in addition, immunocompromised patients (solid organ transplant, bmt, aids, renal failure (patients with renal impairment may develop drug poisoning) or other diseases not mentioned and other diseases treated with biological, immunological and / or steroids in high doses will not be eligible for the study. doses (\> 20 mg prednisone daily). * hypersensitivity to any component of the preparation, severe congestive heart failure, cardiomyopathy, myocarditis, ii-iii degree av block, bradycardia, clinically significant prolongation of the qt interval, or a family history of congenital long qt syndrome, severe ventricular arrhythmias (including torsade de pointes), concomitant use of drugs that prolong the qt interval, hypokalaemia, hypomagnesaemia, * pregnancy, the period of breastfeeding. * parallel intake of memantine or other drugs acting on the cns (neuroleptics, anxiolytics, antiepileptic drugs, antidepressants). * other neurological conditions with agitation or confusion, delirium syndromes or psychoses. * receipt of a partial or full vaccination schedule against sars-cov-2 is also an exclusion criterion from the study.
feasibility study: ulthera® system for the treatment of axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: single-center, randomized, split-body, pilot study, treatment of up to 23 subjects in two treatment groups. subjects will receive two ultherapy treatments at day 0 with follow-ups at 7 and 14 days post-treatment #1, and day 28 with follow-ups are 7, 14, 30, 60, 90 days post-treatment #2.

subjects will be randomized to one of two study groups: * group a: split body treatment. ultherapy to one axilla, sham treatment to the other axilla. * group b: bilateral ultherapy treatments, with a pre-treatment subcutaneous lidocaine injection administered to one axillary side. hyperhidrosis disease severity scale (hdss), gravimetric test and starch iodine test will be obtained at all study visits. patient satisfaction questionnaires will also be obtained at 30, 60 and 90 days post-treatment #2.

Eligibility criteria:
inclusion criteria: * male and female, ages 18-75 * subject is in good health * diagnosis of bilateral axillary hyperhidrosis refractory to previous topical therapies * at least 50 mg of spontaneous resting axillary sweat production in each axilla measured gravimetrically at room temperature/humidity (20 - 25.6°c/20-80%) over a period of 5 minutes. (patients should be at rest for at least 30 minutes after physical exercise including walking.) * hdss score of 3 or 4. * understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period. exclusion criteria: * dermal disorder including infection at anticipated treatment sites in either axilla. * previous botulinum toxin treatment of the axilla in the past year. * expected use of botulinum toxin for the treatment of any other disease during the study period. * known allergy to starch powder or iodine. * secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria. * previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery. * women who are pregnant, lactating, possibly pregnant or planning a pregnancy during the study period.

Keywords: underarm sweating
impact of an emotional robot on quality of working life of caregivers in a geriatric unit

Conditions: Burnout, Professional; Stress; Anxiety

Summary: since february 2016, with the objective of improving the quality of life and the autonomy of residents, the le mans general hospital uses an interactive "emotional" robot within its geriatric wards. this emotional robot, paro, is equipped with a dozen sensors, 3 microphones and interacts with its user: it reacts to touch, voice and heat making small sounds and moves its head, fins and tail. the algorithm that governs paro's behavior allows him to offer a behavioral answer adapted to the user's stimuli. thus, paro is able to communicate beneficial emotions to patients. to this day however there is no published study exploring the effect of such a robot on team dynamics among caregivers in hospital units. our research aims at highlighting the benefits that a healthcare team perceives when working with this tool among patients suffering from dementia.


Eligibility criteria:
inclusion criteria: * non medical caregiver (nurse, nursing aid, orderly, psychological aid worker) working in one of the selected geriatric wards. exclusion criteria: * refusal to participate in the study
efficacy of sildenafil in preterm preeclampsia

Conditions: Preterm Preeclampsia

Summary: randomized controlled trial to assess efficacy of sildenafil in addition to expectant management for the treatment of preterm preeclampsia

preeclampsia is a major cause of maternal mortality. when preeclampsia presents prior to thirty-four weeks of gestation, expectant management is the standard practice in stable patients with the goal of extending pregnancy and therefore decreasing the risk of adverse outcomes in the premature neonate. our aim was to assess the efficacy of sildenafil, a phosphodiesterase inhibitor, versus placebo, in addition to expectant management, for the treatment of preterm preeclampsia to prolong pregnancy.

Eligibility criteria:
inclusion criteria: 1. hospitalized patients of gestational age of ≥24 0/7 weeks to ≤32 0/7 weeks. 2. dating of pregnancy by ultrasound \< or equal to 22 weeks or ivf conception 3. diagnosis of preterm preeclampsia or superimposed preeclampsia exclusion criteria: 1. need for immediate delivery of the fetus 2. known lethal anomaly 3. pre-existing renal disease 4. hypersensitivity to sildenafil 5. pre-gestational diabetes, class c (onset prior to 10-19 or duration 10-19 yrs 6. active peptic ulcer disease 7. undergoing nitrate therapy
detection of hypovolemia using pleth variability index (pvi)

Conditions: Hypovolemia

Summary: the purpose with the planned study is to study pleth variability index (pvi) as a non invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects. lower body negative pressure (lbnp), a well established technique is used to create defined levels of hypovolemia. primary hypothesis: by applying a breathing resistance (positive end expiratory pressure peep) to spontaneous breathing, the respiratory synchronous variation in the pulse oximeter signal (pvi) is enhanced and enables pvi to detect and grade the level of mild hypovolemia. secondary hypothesis: 1) when tidal volume is increased, the respiratory synchronous variation in the pulse oximeter signal (pvi) will also increase. 2) the earlobe is superior to the finger in detecting pvi 3) hemoglobin (hb), detected non invasively by pulse oximetry, is not affected by hypovolemia created by lbnp

the subjects are placed supine on a bed. non invasive equipment for recording pulse and blood pressure is placed on a finger on the right hand. from this equipment total peripheral resistance and cardiac output are recorded. a pulse oximeter for saturation, perfusion index and pvi is placed on a finger and on the ear lobe. data are recorded in parallel from the finger and the ear lobe. in addition non invasive haemoglobin (hb) is recorded from the pulse oximeter on the finger. the subjects breathe through a mask connected to a simple y-connector with an inspiratory valve on one side and an expiratory valve on the other. a positive pressure valve is applied on the expiratory side. tidal volume is measured on-line by a connector connected to a spirometer and the tidal volume is displayed to the subjects. stroke volume, total peripheral resistance and cardiac output is measured using ultra sound via the jugular fossa. baseline data are recorded with the subjects in the supine position breathing with normal tidal volume without peep and without lbnp applied. data are then recorded with lbnp applied in two steps (40 and 15 mmhg). recordings are continued 5 minutes after releasing the negative pressure. data are collected in total in four different series; normal tidal volume without peep; normal tidal volume with peep 5cm h2o; three doubled tidal volume without peep; three doubled tidal volume with peep 5 cm h20. respiratory rate is not controlled. the order of the four series is randomized. between the series a 20 minute period of rest is allowed to the subjects. this period is also necessary to restore steady state between provocations.

Eligibility criteria:
inclusion criteria: * subjects without any heart or lung disease exclusion criteria: * smoking * drugs affecting circulatory or respiratory system

Keywords: hypovolemia lower body negative pressure photoplethysmography
colonic motility in constipation and aging: a study with a new 3d transit system

Conditions: Constipation

Summary: to study the motility of the bowel in constipated patients. looking at the difference between young and elderly patients with constipation.


Eligibility criteria:
inclusion criteria: * constipation exclusion criteria: * constipation caused by other disease
non-invasive assessment of pulmonary artery pressure

Conditions: Pulmonary Hypertension

Summary: the assessment of pulmonary artery pressure (pap) and parameters describing right ventricular function stand in the focus of the diagnosis and clinical management of pulmonary hypertension (ph). right heart catheterization (rhc) is the gold standard method to measure pap and to provide hemodynamic information on right ventricular function. however, due to its invasive nature, rhc is not optimal for screening and for close monitoring of the disease. therefore, the development of non-invasive methods providing reliable pap measurements and right ventricular functional parameters would be of major benefit. today, the most often used comprehensive non-invasive method for these purposes is echocardiography. however, the method has limitations; in many cases pap is significantly under- or overestimated - especially in subjects with co-existing pulmonary diseases. regarding right ventricular function, although novel echocardiography parameters appear to be promising, they have not yet been evaluated in all forms of ph. another emerging non-invasive method is cardiac magnetic resonance imaging (mri). mri is considered to be as gold standard for the non-invasive assessment of right ventricular function. in addition, our group showed that with a special approach ("vortex method"), mri enables the determination of pap with physiologic accuracy, but the method has not yet been validated systematically in different forms of ph. all patients undergoing right heart catheterization in our clinic are candidates for the study. excluded will be patients not eligible for mri or declining to take part in the study. mri and echocardiography will be performed within two weeks of the rhc. hypothesis: 1. mri is superior to echocardiography to non-invasively determine mean pap in a broad collective of patients with ph of diverse ethology. 2. mri derived right ventricular functional parameters correlate better to invasive measurements and to established prognostic parameters than echocardiography derived right ventricular functional parameters. 3. novel right ventricular tissue doppler parameters add substantially to "classical" echocardiography parameters to describe right ventricular function.


Eligibility criteria:
inclusion criteria: patients undergoing right heart catheterization due to clinical reasons - exclusion criteria: patients not eligible for mri, patients not agreeing with investigation -
atrioventricular block and cluster headache (seva)

Conditions: Cluster Headache

Summary: verapamil is a calcium channel blocker widely used to treat cardiovascular diseases however it is also the first line treatment in the prevention of cluster headaches. in france, its prescription in that indication is based on compliance with the temporary recommendation for use (rtu) that insists on the possible the cardiac side effects that can occur as the doses required for cluster headache are significantly higher than the doses used in cardiology.


Eligibility criteria:
inclusion criteria: * patient 18 years old, and older * patient suffering from cluster headache (according to the l'ichd-3 diagnostic criterias) * patients affiliated to the social security * patient that has given his full written consent to participate in the study * female patients participating in the study must be using an efficient contraception for more than 1 month prior to the beginning of the study exclusion criteria: * patient presenting contraindications to the use of verapamil * patient observing a treatment with ivabradine (procoralan®), bétablockers, colchicine, l'esmolol, triazolam, quinidine. * patient under justicial protection * patient breastfeeding, or pregnant * patient suffering from a neuromuscular transmisson disease * patient with a pacemaker